Study Stopped
Study closed following Phase I portion, insufficient activity to continue to Phase II.
Imatinib in Combination With Dacarbazine and Capecitabine in Medullary Thyroid Carcinoma
A Phase I/II Study to Evaluate the Efficacy and Toxicity of Imatinib Mesylate in Combination With Dacarbazine and Capecitabine in Medullary Thyroid Carcinoma
1 other identifier
interventional
21
1 country
1
Brief Summary
Objectives: Primary objectives: To determine the maximum tolerated doses (MTD) for the combination of imatinib mesylate, capecitabine, and dacarbazine in patients with solid tumors. To determine the overall tumor response rate to imatinib mesylate in combination with capecitabine and dacarbazine as first line and second line therapy in advanced metastatic medullary thyroid carcinoma. To determine the tolerability (toxicity) of this regimen. Secondary objectives: To determine the median overall survival (OS) and time to progression (TTP) for patients treated with this combination.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Dec 2004
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 18, 2006
CompletedFirst Posted
Study publicly available on registry
July 20, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedDecember 17, 2014
December 1, 2014
1.9 years
July 18, 2006
December 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum tolerated doses (MTD) for the combination of imatinib mesylate, capecitabine, and dacarbazine
The MTD is defined as the dose level below that producing dose limiting toxicity (DLT; i.e. any Grade 4 hematologic toxicity and /or non hematological toxicity \>/= Grade 3 in 2/6 participants).
21 day cycle
Secondary Outcomes (1)
Objective Response Rate
Minimally 9 weeks (overall study period 5 years)
Study Arms (1)
Capecitabine + Dacarbazine + Imatinib
EXPERIMENTALCapecitabine starting Dose 500 mg/m\^2 twice a day Days 1-14 of 21 Day Cycle. Dacarbazine starting Dose 250 mg/m\^2 a day on Days 1-3 of 21 Day Cycle. Imatinib starting Dose 400 mg a day on Days 1-21 of 21 Day Cycle.
Interventions
Starting Dose 500 mg/m\^2 twice a day Days 1-14 of 21 Day Cycle.
Starting Dose 250 mg/m\^2 a day on Days 1-3 of 21 Day Cycle.
Starting Dose 400 mg a day on Days 1-21 of 21 Day Cycle.
Eligibility Criteria
You may qualify if:
- Age greater than 16 years old.
- Signed informed consent.
- During the phase I portion of the trial, any patient with a proven solid tumor for which no curative or standard treatment is available is eligible. However, for the phase II portion of the trial, patients are required to have medullary thyroid carcinoma that is unresectable or metastatic.
- For the phase I portion of the protocol, there is no limit to the amount of prior therapy participants may have received. For the phase II portion of the trial, 0-1 prior regimens are allowed.
- ECOG performance status must be 0-2.
- Adequate hepatic, renal, and bone marrow function: Absolute neutrophil count greater than/equal to 1,500/uL; platelets greater than/equal to 100,000/uL; total bilirubin less than/equal to 1.5 X institution upper limits of normal (ULN); AST (SGOT)/ALT (SGPT) less than/equal to 2.5 X institutional ULN; Creatinine less than/equal to 1.5 mg/dL
- Female patients of childbearing potential must have a negative pregnancy test within 7 days before initiation of study drug dosing. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug.
- Patients may have received prior radiation treatment but the last fraction of radiation treatment must have been completed at least 4 weeks prior to entry on this study.
- Patients may have been treated with surgery but the surgical intervention must have been done at least 3 weeks prior to entry on this study.
- In the phase I part of the trial, measurable disease is not required. Radiographic and measurable evidence of disease is required for the phase II part of the trial. To be considered evaluable for complete or partial response, patients must have at least one measurable lesion as per the modified RECIST Criteria. If radiation was previously received, measurable disease must occur outside the previous radiation field, unless disease progression has been documented.
- Both men and women and members of all ethnic groups are eligible for this trial.
You may not qualify if:
- In previously treated patients, patients should not have received prior dacarbazine, imatinib mesylate, 5-fluorouracil, or capecitabine. This requirement does not apply to the phase I patients.
- Uncontrolled intercurrent illness including, but not limited to, active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmias not well controlled with medication, myocardial infarction within the previous 6 months, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients who have had chemotherapy within 3 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 28 days earlier.
- Patients may not be receiving any other investigational agents, or have participated in any investigational drug study within 28 days preceding start of study treatment.
- The teratogenic potential of this combination is currently unknown. Women who are pregnant or lactating are excluded.
- History of any other malignancy in the last 5 years, except that patients with a prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Patients with treated disease processes believed to be associated with MEN2, such as pheochromocytomas and primary hyperparathyroidism are allowed in the study.
- Concomitant use of warfarin is not allowed. Low molecular weight and standard heparin use is allowed.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Novartis Pharmaceuticalscollaborator
Study Sites (1)
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Halperin DM, Phan AT, Hoff AO, Aaron M, Yao JC, Hoff PM. A phase I study of imatinib, dacarbazine, and capecitabine in advanced endocrine cancers. BMC Cancer. 2014 Aug 2;14:561. doi: 10.1186/1471-2407-14-561.
PMID: 25086465DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James Yao, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2006
First Posted
July 20, 2006
Study Start
December 1, 2004
Primary Completion
November 1, 2006
Study Completion
August 1, 2013
Last Updated
December 17, 2014
Record last verified: 2014-12